SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients

Type 2 Diabetes Clinical Trial

— SLEEVEDIAB  

Official title:

Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02076880
• Other study ID #: 9016
• Secondary ID: 2012-A00962-41
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 2, 2014
• Start date: November 2013
• Est. completion date: November 2017

Study information

• Verified date: September 2013
• Source: University Hospital, Montpellier
• Contact: Florence GALTIER, MD
• Email: f-galtier[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: FRANCE: ANSM: Agence Nationale de Sécurité du Médicament (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• written informed consent

• Age between 18-65 years (inclusive)

• Men or women receiving effective contraception, postmenopausal or sterile

• type 2 diabetes treated with no drugs or oral anti-diabetic agents metformin, sulfonylurea or glinides

• Body mass index 35 kg / m² or above

• eligible to bariatric surgery according to HAS criteria

Exclusion Criteria:

• Treatment of diabetes with GLP1 analogues, DPP-IV (dipeptidyl-peptidase IV) or insulin

• Treatment with drugs that modify glucose homeostasis: glucocorticoids, anorexigens, antihistaminics, psychotropic drugs especially serotonergic antidepressants (except for the occasional use of a hypnotic or anxiolytic), atropine, laxatives, thyroid hormones (with the exception of a substitution dose ensuring a stable euthyroid at baseline), beta blockers, diuretics

• Pregnancy, intention of being pregnant, breastfeeding.

• Inability to understand the nature and aims of the study or to communicate with the investigator- High probability of non

• compliance with the protocol

• Simultaneous participation in another trial

• No affiliation to the French social security

• Loss of personal capacity resulting in state protection

• Deprivation of liberty by judicial or administrative decision

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity, Morbid
• Severe Obesity
• Type 2 Diabetes

Intervention

Other:
• Caloric restriction
Caloric restriction of 1000 kcal per day compared to the usual food intake. usual breakfast of the patient (possibly limited in quantity) midday and evening meals from mixed and dehydrated meals, soups with protein and dairy desserts sweetened
• No caloric restriction
No change in eating habits to patients in this arm

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of area under the curve of post prandial glycemia		Baseline to day 7 after surgery	No
Secondary	Change in insulin sensitivity, Change in insulin secretion, Change in incretins		Blood samples at D-15, D-7 before surgery, D7, D80, D170, D350 after surgery	No